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Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis

Primary:* To evalaute the efficacy of three doses of norUDCA vs. placebo for the treatment of PSC* To identify efficacious norUDCA dose(s) for the treatment of PSC for further evaluation in phase III. Secondary:* To study safety and tolerability (…

A Randomised, Double-blind, Active Treatment Study to Induce
Clinical Response and/or Remission with GSK1605786A in
Subjects with Moderately-to-Severely Active Crohn*s Disease

Primary Objective:To induce clinical response (CDAI decrease from baseline * 100 points) and/or remission(CDAI <150) following 12 weeks of treatment with one of two active doses ofGSK1605786A for qualification of subjects for enrolment into a…

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Primary Objective * To demonstrate the efficacy of tofactitinib in inducing remission in subjects with moderately to severely active UC. Secondary Objectives * To evaluate the safety and tolerability of tofactitinib in subjects with moderately to…

THE CUPIDO STUDY:
The effect of the multispecies probiotic Ecologic 825 versus placebo in Ulcerative Colitis patients

To investigate whether a specifically designed multispecies probiotic mixture (ecologic 825®), as adjuvant therapy, can contribute to an improvement of intestinal permeability, microbiota composition, disease activity and inflammatory markers in…

A study to investigate the safety, tolerability and absorption and elimination of CCX507-B, a new drug for the treatment of patients with inflammatory bowel diseases, in healthy male and female subjects.

The purpose of the study is to investigate to what extent CCX507-B is safe and tolerated. It will also be investigated how quickly and to what extent CCX507-B is absorbed and eliminated from the body (this is called pharmacokinetics). In addition,…

Double-blind, double-dummy, randomised, placebo-controlled, multi-centre phase III study on the efficacy and tolerability of a 8-week treatment with 9 mg budesonide vs. 3 g mesalazine vs. placebo in patients with lymphocytic colitis

To evaluate the efficacy of 9mg budesonide/day and 3g mesalazine/day compared to placebo for the induction of remission in lymphocitic colitis.

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis

The primary hypothesis of this study is that a dose-response relationship exists between disease activity as measured by the change from baseline in the Mayo score at Week 8 and JNJ-54781532 treatment regimens in subjects with moderately to severely…

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn's Disease

Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn*s Disease.

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohnâ¤*s Disease

Primary: to assess the efficacy of GSK1605786A compared with placebo in maintaining remission. Secondary: Safety, quality of life, healthcare resource utilisation, work productivity.

Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn*s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

Primary ObjectiveThe primary objective of this study will be to compare the efficacy of infliximab with that of placebo in the prevention of clinical recurrence of CD through Week 76, defined as a composite endpoint that requires endoscopic…

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease

Primary Objective• To determine the effect of vedolizumab induction treatment on clinical remission at Week 6 in the subgroup of patients defined as having failed tumor necrosis factor alpha (TNFa) antagonist therapy (TNFa subpopulation)Secondary…

Transplantation of faeces in ulcerative colitis; restoring nature*s homeostasis

Primary objective: to study the effect of faecal transplantation in a phase II randomised placebo controlled design on simple clinical colitis activity index (SCCAI) and endoscopic Mayo score. Secondary objective: to study intra individual changes…

A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)

Primary objective:Compare the efficacy of BMS-936557 versus placebo for induction of clinical remission (defined as Mayo score * 2 points with no individual subscore > 1 point) at Week 7 (IP-50).Secondary objective* Compare the efficacy of…

Effect of AN-PEP enzyme on gastrointestinal breakdown of immunogenic gluten epitopes in healthy subjects

Primary: • Assess effect of AN-PEP on gluten epitope degradation in the duodenumSecondary: • Assess effect of AN-PEP on gluten epitope degradation in the stomach• Assess effect of meal caloric content on the efficacy of AN-PEP on gluten epitope…

A phase II, 20-week, multi-centre, randomised, double-blind, placebo-controlled, parallel group proof of concept study to investigate the efficacy and safety of GSK1605786 for treatment of patients with active Ulcerative Colitis (CCX115393)

Primary: efficacy of GSK1605786 at week 12 following twice daily administration at 500 mg in patients with active ulcerative colitis. Secondary: safety and tolerability, time course of the efficacy of GSK1605786 continued for up to 16 weeks, anti-…

The effects of oral administration of lactobacillus plantarum WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450 on small intestinal mucosa and barrier function

This research aims to investigate the effects of three bacteria in the small intestine. This study will provide detailed information on all processes in the small intestine. By the used analytical technique, including gene expression technology, not…

A two-part, multi-centre, randomized, placebo-controlled, double-blind study, of TRK-170 for the treatment of Crohn's disease.

The purpose of the collected study information is research, development and safety analysis of TRK-170.

A Randomized, Double-blind, Multiple Dose Placebo-Controlled Study to
Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with
Moderate to Severe Ulcerative Colitis

Evaluation the effect of AMG 181 on induction of remission in subjects with moderate to severe UC at week 8 as assessed by a total Mayo Score >= 2 points, with no individual subscore > 1 point.

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN*S DISEASE (OPERA)

The primary objective is to determine the number of subjects that experience a decrease in CDAI (Crohn*s Disease Activity Index) of at least 70 points by the Week 8 or Week 12 assessment.

Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST 261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment

Ulcerative colitis is an inflammatory disease that affects the colon. The extent and severity of the disease may vary: it is possible that the disease only the rectum (the lower part of the colon) found, but the disease may extend over the entire…